A trial in patients with relapsing remitting multiple sclerosis (RRMS) Main objectives: * To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d. * To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB). * To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI). * To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod.
Patients are screened and must sign informed consent at visit 1. At the 2nd visit, all patients receive a baseline infusion of Natalizumab, which is followed by an 8 week washout Phase. After the washout Phase all patients receive fingolimod for 32 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Fingolimod: 0.5 mg p.o. (o.i.d)
Natalizumab: 300 mg i.v. (once at baseline);
Universitaetsklinikum Muenster, Department of Neurology
Münster, Germany
RECRUITINGTemporal changes in the expression of CD49d
First Co-Primary Objective; Flow-cytometric analysis of temporal changes in the expression of CD49d of PBMCs; unit of measure: mean fluorescence intensity (MFI)
Time frame: weeks: 12, 16, 20, 24, 28, 32
Migratory capacity of immune cells
Second Co-Primary Objective; in-vitro model of the blood-brain-barrier (BBB) with subsequent flow-cytometric analysis and bead based quantification assessing temporal changes in the migratory capacity of immune cells; unit of measure: fluorescence intensity
Time frame: weeks: 12, 32
MRI disease activity over time by GD+, T2w and DTI
Number of active (new or newly enlarging) lesions are assessed over time by MRI (changes in Gadolinium (GD+), T2w lesions and DTI (Diffusion Tensor Imaging))
Time frame: weeks: 0, 8, 12, 16, 24, 32
MRI disease activity over time by T1w / FLAIR
Number of active (new or newly enlarging) lesions are assessed over time by MRI (T1w / FLAIR (Fluid Attenuated Inversion Recovery)
Time frame: weeks: 0, 8, 12, 16, 24, 32
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